UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009728 |
|---|---|
| Receipt number | R000011403 |
| Scientific Title | Effect of combination of intravenous propofol and inhaled nitrous oxide: a randomized clinical trial |
| Date of disclosure of the study information | 2013/01/08 |
| Last modified on | 2018/08/29 11:36:00 |
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Basic information
Public title
Effect of combination of intravenous propofol and inhaled nitrous oxide: a randomized clinical trial
Acronym
Effect of combination of intravenous propofol and inhaled nitrous oxide
Scientific Title
Effect of combination of intravenous propofol and inhaled nitrous oxide: a randomized clinical trial
Scientific Title:Acronym
Effect of combination of intravenous propofol and inhaled nitrous oxide
Region
| Japan |
Condition
Condition
healthy adult volunteers
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether N2O added to intravenous sedation with propofol can reduce the occurrence of hypotension and to improve quality of sedation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamics, heart rate variability, depth of sedation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sedation with and intravenous propofol
Interventions/Control_2
sedation with and intravenous propofol and inhaled nitrous oxide
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers
Key exclusion criteria
A history of cardiovascular disease, hypertension, respiratory disease and dysautonomia were considered criteria for exclusion from the study.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hanamoto |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthsiology
Zip code
Address
1-8, Yamadaoka, Suita, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthsiology
Zip code
Address
1-8, Yamadaoka, Suita, Osaka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 08 | Day |
Last modified on
| 2018 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011403
